Guided Therapeutics Enters into LuViva® Advanced Cervical Scan License Agreement for China

NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and
painless testing platform based on its patented biophotonic technology,
announced today that it has reached a licensing agreement with Shenghuo
Medical, LLC, for exclusive sales and manufacturing rights of the
LuViva® Advanced Cervical Scan for China and several additional
Southeast Asian countries. Shenghuo brought Chinese investors into GTHP
last year and currently owns the distribution rights to China.
The terms of the licensing agreement include $200,000 in near-term cash
payments, the potential for up to $1.0 million to pay for advancing U.S.
Food and Drug Administration approval for LuViva, funding to secure
Chinese regulatory approval of LuViva and a royalty payable to Guided
Therapeutics on disposables sold in the territories. Shenghuo also has
the right to manufacture the LuViva and disposables under certain
conditions.
“We are pleased to be continuing with Shenghuo to open up this valuable
market to LuViva,” said Gene Cartwright, CEO and President of Guided
therapeutics. “The agreement also opens up the possibility to bring
efficiencies to our manufacturing processes and provides funding for
Chinese regulatory approval.”
China is the second largest medical device market in the world,
according to the U.S. Department of Commerce. Approximately 390 million
Chinese women are between 25 and 64 years old, the prime age for
cervical cancer screening. Prior to commercial sales, LuViva would need
approval from the Chinese Food and Drug Administration. The Company
currently anticipates interim device and disposable sales for clinical
study and demonstration purposes. In Hong Kong, the Company believes the
time to commercial sales is quicker, with device registration, rather
than approval required.
Worldwide, the market for cervical cancer screening and diagnostics, as
currently practiced using cytology (Pap test) for primary screening, is
estimated at $6 billion and is projected to grow to almost $9 billion by
2020. There are about 2.6 billion women aged 15 years and older who are
at risk of developing cervical cancer worldwide.
About LuViva^® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the
cervix with light and uses spectroscopy to measure how light interacts
with the cervical tissue. Spectroscopy identifies chemical and
structural indicators of precancer that may be below the surface of the
cervix or misdiagnosed as benign. This technique is called biophotonics.
Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory
analysis or a tissue sample, and is designed to provide results
immediately, which may result in eliminating costly, painful and
unnecessary additional testing. LuViva is intended for use with women
who have undergone initial screening and are called back for follow up
with a colposcopy examination, which in many cases, involves taking a
biopsy of the cervix. It has also been used in clinical studies in
Turkey and Nigeria as a means to screen women for cervical cancer where
the availability of infrastructure necessary for Pap and HPV testing is
restricted. The device is used in conjunction with the LuViva^®
Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of a rapid and
painless testing platform based on its patented biophotonic technology
that utilizes light for the early detection of disease at the cellular
level. The Company’s first product is the LuViva®Advanced
Cervical Scan, a non-invasive device used to detect cervical disease
instantly and at the point of care. In a multi-center clinical trial
with women at risk for cervical disease, the technology was able to
detect cervical cancer up to two years earlier than conventional
modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva^® Advanced
Cervical Scan is an investigational device and is limited by federal law
to investigational use in the U.S. LuViva, the wave logo and “Early
detection, better outcomes” are registered trademarks owned by Guided
Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and
subject areas discussed in this news release that are not historical or
current facts deal with potential future circumstances and developments.
The discussion of such matters and subject areas is qualified by the
inherent risks and uncertainties surrounding future expectations
generally and also may materially differ from Guided Therapeutics’
actual future experience involving any of or more of such matters and
subject areas. Such risks and uncertainties include those related to the
early stage of commercialization of products, the uncertainty of market
acceptance of products, the uncertainty of development or effectiveness
of distribution channels, the intense competition in the medical device
industry, the sufficiency of capital raised in prior financings and the
ability to realize their expected benefits, the uncertainty of future
capital to develop products or continue as a going concern, the
uncertainty of regulatory approval of products, and the dependence on
licensed intellectual property, as well as those that are more fully
described from time to time under the heading “Risk Factors” in Guided
Therapeutics’ reports filed with the SEC, including Guided Therapeutics’
Annual Report on Form 10-K for the fiscal year ended December 31, 2015
and subsequent filings.